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Pairing Oral Immunotherapy with Biological Medication for Allergic Asthma Reduces Dosing-Related Side Effects and Time Needed to Reach Maintenance Dose

SAN DIEGO, CA – Omalizumab is an immunomodulator medication, which means it acts by directly changing the behavior of the immune system. While it is currently used to treat severe allergic asthma in those who are 12 years of age and older, a late-breaking abstract presented at the 2014 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) found that there were benefits to combining omalizumab with oral immunotherapy to treat milk allergy. Combining the two reduced dosing-related side effects and the time needed to reach the maintenance dose.

“There are two phases with oral immunotherapy: the build-up phase and the maintenance phase. The build-up phase involves consuming increasing amounts of the allergen, while the maintenance phase begins once the effective dose is reached,” explained Hugh A. Sampson, MD, FAAAAI, an author of the study and a past President of the AAAAI. “The effective maintenance dose depends on your level of sensitivity to the allergen and your response to the build-up phase.”

In the first study of its kind, researchers had a sample of 57 milk-allergic subjects spanning ages 7 to 32 who were randomized to receive either blinded omalizumab or a placebo for 16 months. Doses of milk oral immunotherapy began after four months of receiving either the omalizumab or the placebo. Over a period of 22 to 40 works, build-up doses were given while escalating to the maintenance dose. The goal was to reach 3.84 grams of milk protein per day.

Three subjects did drop out of the study before reaching the start of oral immunotherapy dosing.

As they analyzed their results, researchers had to make sure the omalizumab and placebo groups were similar in nature as they began the study. They found that at the time of enrollment, there were no statistically significant differences between the two groups as far as age, levels of milk specific-IgE, size of wheal seen after a milk skin prick test, and the oral food challenge dose where they experienced a first symptom.

The results showed significant differences between the omalizumab and placebo groups regarding the number of oral immunotherapy dose-related symptoms per person during the 16 months of dose escalation and maintenance therapy, reactions during dosing that required treatment, and the need for epinephrine. In addition, significantly fewer doses were needed before reaching the maintenance dose in the omalizumab group.

“This is the first randomized, double-blinded, placebo-controlled study that shows the benefits of pairing omalizumab with oral immunotherapy to treat food allergy,” said Dr. Sampson. “The next step is to examine whether omalizumab improves how quickly desensitization and tolerance are achieved.”

The AAAAI represents allergists, asthma specialists, clinical immunologists, allied health
professionals and others with a special interest in the research and treatment of allergic disease. Established in 1943, the AAAAI has more than 6,800 members in the United States, Canada and 60 other countries.

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Editor's notes:
· This study was presented during the 2014 Annual Meeting of the American Academy of
Allergy, Asthma & Immunology (AAAAI) on February 28-March 4 in San Diego.
However, they do not necessarily reflect the policies or the opinions of the AAAAI.
· A link to all abstracts presented at the Annual Meeting is available atannualmeeting.aaaai.org (Note to media: request/see abstract L19)